NDC codes

FDA NDC Directory
Product NDC (as listed)70700-326Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70700-0326Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70700-326-50707000326507070003265050 TABLET in 1 BOTTLE (70700-326-50)Marketed from Sep 6, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Gallifrey
Generic name (nonproprietary)
norethindrone acetate
Active ingredients
Norethindrone acetate — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Xiromed LLCNDC labeler code 70700
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205278
Marketing start
Listing expires
Other FDA classes
Progesterone Congeners (Chemical structure)
Identifiers
Product ID 70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75SPL ID 87e7c941-eb02-5980-fc0e-08aee9b00f75SPL set ID 26130af6-221b-2349-81b6-0c0132d6e524RxCUI 1000405, 2696255UNII 9S44LIC7OJ
Pharmacologic class
Progestin

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470700032650 followed by a unit qualifier and the quantity

Package 70700-0326-50. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Gallifrey is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70700-326

What is NDC 70700-326?
70700-326 is the product NDC for Gallifrey (norethindrone acetate), Norethindrone acetate 5 mg/1 tablet, listed with the FDA by Xiromed LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gallifrey (Norethindrone Acetate).
What is the active ingredient?
Norethindrone acetate.
Who is the labeler?
Xiromed LLC, NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gallifrey?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in